Class II U.S. Food and Drug Administration

Medtronic MiniMed, Inc. Paradigm REAL-Time Veo Insulin Pump recall: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series

Recall published 7 months ago

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1752-2026
Published
April 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic MiniMed, Inc.
Product type
Medical devices
Units affected
55,724
Distribution
Nationwide
Made in
United States
Lot / code info
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Veo: 00613994717801, 00613994713834, 00613994713841, 00613994870414, 00613994870377, 00613994870407, 00643169378636, 00613994924957, 00613994717672, 00613994715531, 00613994715555, 00613994715562, 00613994409423, 00613994951502, 00643169026131, 00613994622600, 00613994407740, 00643169077737, 00643169464537, 00643169305038, 00643169500259, 00643169503229, 00643169528789, 00643169533776, 00613994151766, 00643169711440, 00763000084370, 00763000161224, 00763000161262, 00643169464520, 00613994963376, 00643169026100, 00613994924247, 00643169299757, 00643169400931, 00643169400986, 00643169535749, 00643169535794, 00643169519190, 00643169579507, 00643169519091, 00763000084349, 00763000084356, 00763000161248, 00763000048853, 00763000161231, 00643169729445, 00643169846036, 00643169579453, 00613994714183, 00613994716156, 00613994657671, 00643169515741, 00643169579514, 00643169579538, 00643169579477, 00643169579569, 00643169579392, 00643169579583, 00643169579552, 00643169579576, 00643169846012, 00643169845909, 00643169845947, 00643169845992, 00643169846043, 00763000067663, 00643169846005, 00763000001247, 00643169578470, 00763000059729, 00763000048860,00763000048914, 00763000048839, 00763000048884, 00763000048822, 00763000048808, 00763000048938, 00763000048815, 00763000048921, 00763000048891, 00763000048785, 00763000048945, 00763000048877, 00763000048846, 00613994924438, 00613994924223, 00613994924391, 00613994924339, 00613994924346, 00613994924216, 00613994924278, 00763000084387, 00643169196766, 00613994611697, 00613994715944, 00613994714190, 00613994716002, 00613994716248, 00613994717719, 00613994716194, 00613994716361, 00613994716422, 00613994716415, 00613994716200, 00613994716354, 00613994716187, 00613994716323, 00613994716408, 00613994716385, 00613994716378, 00613994716217, 00613994863560, 00613994863515, 00613994863607, 00613994863409, 00613994863614, 00613994863355, 00613994863393, 00613994863430, 00613994863416, 00613994863553, 00613994863577, 00613994863539, 00613994863584, 00613994974273, 00613994870278, 00613994863621, 00613994924032, 00613994924254, 00613994863638, 00613994924353, 00613994924414, 00613994924445, 00613994863522, 00613994924407, 00613994863546, 00613994924384, 00613994924230, 00613994924421, 00613994750969, 00643169196674, 00643169196612, 00643169196704, 00643169196735, 00643169196698, 00643169196711, 00643169196773, 00643169196681, 00643169196728, 00643169196759, 00643169196742, 00643169196780, 00643169196636, 00643169196650, 00643169341654, 00643169317550, 00643169317574, 00643169317611, 00643169317567, 00643169317659, 00643169317642, 00643169317666, 00643169317536, 00643169306912, 00643169317581, 00643169341647, 00643169341661, 00643169324039, 00643169318960, 00643169317604, 00643169317598, 00643169317628, 00643169341630, 00643169324084, 00643169326668, 00643169317635, 00643169319370, 00643169381827, 00643169378995, 00643169379008, 00643169381810, 00643169378988, 00643169381780, 00643169381834, 00643169381773, 00643169381889, 00643169381872, 00643169381803, 00643169381797, 00643169381896, 00643169381766, 00643169381841, 00643169381902, 00643169428232, 00643169383838, 00643169379572, 00643169378704, 00643169411692, 00643169382725, 00643169495593, 00643169381865, 00763000084363, 00643169376090, 00643169579545, 00643169579521, 00643169593404, 00643169579439, 00643169579415, 00643169579484, 00643169579491, 00643169742048, 00643169579408, 00643169579422, 00643169845985, 00763000161279, 00763000217396, 00643169845954, 00643169845930, 00643169846067, 00643169846050, 00643169845961, 00643169846029, 00763000161255, 00643169845923, 00763000048907, 00763000048792: Labeling/Packaging; INSTR, INSULIN PUMP 554/754 (6025362 1) INSTRUCTIONS FOR USE, 554/754, DE (6025362-071 4); INSTR,INSULIN PUMP, 554/754 (6025362-022 7); INSTR,INSULIN PUMP, 554/754 (6025362-021 2); INSTR, 554/754, EN, A52 (6025362-024 1); INSTR. FOR USE, 554/754, EN (6025362-023 2); INSTR., INSULIN …
UPC codes
00613994717801, 00613994713834, 00613994713841, 00613994870414, 00613994870377, 00613994870407, 00643169378636, 00613994924957, 00613994717672, 00613994715531, 00613994715555, 00613994715562, 00613994409423, 00613994951502, 00643169026131, 00613994622600, 00613994407740, 00643169077737, 00643169464537, 00643169305038

Products covered by this recall

Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

Check your product

The notice names 20 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00613994717801
  • 00613994713834
  • 00613994713841
  • 00613994870414
  • 00613994870377
  • 00613994870407
  • 00643169378636
  • 00613994924957
  • 00613994717672
  • 00613994715531
  • 00613994715555
  • 00613994715562
  • 00613994409423
  • 00613994951502
  • 00643169026131
  • 00613994622600
  • 00613994407740
  • 00643169077737
  • 00643169464537
  • 00643169305038

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medtronic MiniMed, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medtronic MiniMed, Inc. — 18000 Devonshire St, Northridge, CA, 91325-1219

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic MiniMed, Inc. medical devices recalled?

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00613994717801, 00613994713834, 00613994713841. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls